MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 5F MINI DIGNITY CT PORT

Model Number	MICTI5004SM
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are currently waiting for the device to be returned for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The port lumen cracked just before the port stem.The lumen was replaced.
Additional Manufacturer Narrative
The port was returned for evaluation with the lumen locked to it.Visual inspection confirms a leak just before the port stem.There is a tear in the lumen that appears to go half-way around the lumen.A supplier corrective action request was issued to the contract manufacturer.The contract manufacturer reviewed the manufacture records for the lot number reported and found it was manufactured according to specification with no non-conformances or abnormalities.It was noted that the lumen does not go through any assembly process that would require cutting or exposure to sharp objects.The returned device was evaluated and the complaint was confirmed.The components of the device were found to be within specification.It was also noted that the port and lumen were returned attached and locked to each other.These devices are packaged and shipped detached from one another.The extra handling required to attach the lumen to the port stem could have contributed to the event.A root cause cannot be determined but is most likely not manufacture related.The instructions for use (ifu) contains the following caution: prior to advancing the catheter lock, ensure that the catheter is properly positioned.A catheter not advanced to the proper region may not seat securely and lead to dislodgment and extravasation.The catheter must be straight with no sign of kinking.A slight pull on the catheter is sufficient to straighten it.Advancing the catheter lock over a kinked catheter may damage the catheter.Do not hold the catheter or catheter lock with any instruments that could potentially damage either piece (e.G., hemostats).Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5F MINI DIGNITY CT PORT
• Common Device Name: CT PORT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10057229
• Report Number: 2518902-2020-00023
• Device Sequence Number: 3293472
• Product Code: LJT
• UDI-Device Identifier: 00884908089653
• UDI-Public: 884908089653
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 07/31/2024
• Device Model Number: MICTI5004SM
• Device Catalogue Number: MICTI5004SM
• Device Lot Number: MNRF610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention